Due Diligence Solutions fromthoughttofinish

Due Diligence Solutions

ELIQUENT understands the complex regulatory environment within which life sciences transactions take place. ELIQUENT regularly partners with investors to evaluate potential issues and regulatory risks that may be identified during life sciences transactions. Our team of experts provide investors with extensive research, regulatory history assessments, and recommendations on the path forward for potential deals that require regulatory risk analyses before and after decisions and transactions

ELIQUENT’s due diligence services are more than a compilation of public data – we go a step further by enabling the vast institutional knowledge of our regulatory experts to provide in-depth analyses tailored to our clients’ specific needs. ELIQUENT’s multidisciplinary team uses its extensive expertise to perform risk assessments that take into account business objectives, transaction timelines, and the industry and regulatory landscape. The result is an unbiased expert analysis of both expected and unexpected regulatory risks

ELIQUENT’s unique platform goes beyond traditional consulting to deliver full-service support. Our solutions address the entire product lifecycle with best-in-class insight and guidance that bridges the spectrum of regulatory challenges. 

From the earliest phases of development, through regulatory submissions, to post-approval support, ELIQUENT’s robust blend of technical skill and clinical expertise guide companies to approval and beyond.

Buy-Side Transactions

Our buy-side due diligence solutions empower investors with comprehensive insights to confidently navigate opportunities and achieve strategic objectives.

Scientific Rigor

With experience across the landscape of therapeutic areas and modalities, the ELIQUENT team provides the technical and scientific expertise investors need when considering a life sciences transaction. 

Risk Mitigation

Investing in the life science arena comes with inherent risks. We go beyond identifying risks by providing strategic recommendations to mitigate them effectively, safeguarding your investments.

Market Intelligence

ELIQUENT’s industry knowledge and regulatory expertise offers invaluable market insights, enabling you to anticipate trends, assess competitive landscapes, and capitalize on emerging opportunities.

Sell-Side Transactions

ELIQUENT provides clarity and an objective viewpoint, thereby maximizing value in a transaction, and empowering companies to make informed decisions.

Program Roadmap

ELIQUENT partners with companies to evaluate, prioritize, and optimize commercial assets and programs. By identifying areas for improvement and value enhancement, our team of experts create a roadmap to maximize the prospects for successful regulatory outcomes.

Risk Assessment

Our in-depth assessments go beyond identifying regulatory risks – the ELIQUENT team delivers strategic and technical recommendations for system-wide quality and regulatory enhancements.

Industry Insights

ELIQUENT provides companies with critical insights by monitoring and analyzing the life sciences sector for emerging trends, evolving regulatory reforms, and changes to the competitive landscape.

Supported more than 160 diligence deals since 2019

120+ diligence projects focused on

drug, biologic, vaccine, or CGT

Partnered on diligence engagements with 25+

of the top healthcare private equity firms globally

Diligence support for over $11 billion in realized client investments

Our unprecedented assembly of regulatory leaders, industry experts, and technical specialists set the standard for regulatory consulting excellence. With decades of experience in senior positions at the FDA, EMA, and throughout industry, ELIQUENT’s team of respected professionals brings unmatched expertise that companies need when working directly with the regulators and when navigating today’s evolving regulatory environment.

As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. ELIQUENT’s highly specialized experts provide both strategic direction and technical support from the earliest phases of development to post-approval regulatory support.

Product Development

Evaluation of clinical development plans, including review of clinical and nonclinical data, FDA correspondence, safety reporting, and sponsor proposals for future clinical studies.

Pathway Evaluation

Determine eligibility for special designation(s), including priority review, fast track, accelerated approval, breakthrough therapy designation, and regenerative medicine advanced therapy designation.

Regulatory Submissions

Review of pending product submissions to assess completeness and approval prospects, including FDA information requests, mid and late-cycle meetings, advisory committee outcomes, labeling negotiations, and inspectional results.

Compliance Status

Analysis of target company’s FDA compliance and enforcement history, including a review of FDA correspondence relating to compliance matters and identification of outstanding or pending compliance and remediation actions.

Distribution & Supply Chain

Assessment of import-export practices, supply chain audit reports, outsourcing arrangements, and distribution procedures.

Preclinical & Clinical Systems

Assessment of compliance with FDA current good laboratory practice (GLP) and good clinical practice (GCP) regulations. 

Reporting Requirements

Confirm that the target company has complied with all requirements for registration, authorization, filing, and listing associated with approved products, including user fee payments and fulfillment of postmarket obligations. 

Quality Manufacturing

Evaluation of the target company’s compliance with FDA quality and manufacturing regulations related to inspections, standard operating procedures, quality assurance activities, and relevant contract manufacturers.

Adverse Event Reporting

Review of adverse event reports (AERs) and good manufacturing practice complaints to ensure that the target company has taken appropriate measures for review and investigation. 

Marketing & Promotion

Evaluation of promotional practices and marketing materials, including labeling claims, promotion of unapproved products or off-label uses, and related FDA correspondence or enforcement actions. 

Expertise beyond borders. ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.

United States

ELIQUENT is a leading Food & Drug Administration (FDA) regulatory consulting firm that provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies.
Our experts have shaped the landscape of FDA regulatory policy and strategy for decades. We bring this unrivaled knowledge and unique insight to our work with clients every day.

Europe

The ELIQUENT team applies their deep and diverse knowledge of European regulations to keep clients in lock-step with evolving global standards. With decades of experience in the European market, our team understands the intricacies of the European Medicines Agency (EMA) and offers tailored solutions to ensure products meet and exceed the needs of our clients.

Asia

ELIQUENT offers regionally specialized solutions for the innovators across Asia. Our comprehensive solutions include expert guidance to innovators seeking approval in Japan, the third-largest pharmaceutical market in the world. Explore ELIQUENT’s solutions for clients in Japan’s life sciences market.

Explore ELIQUENT Japan >>

ELIQUENT’s foundation is built on experts with the foremost strategic and technical skill across markets, pathways, and global regulations. ELIQUENT’s specialized solutions showcase our collective capabilities and combined expertise. Together, we create a full-service model that equips clients with a premier regulatory resource.

Market Solutions

Guided by decades of regulatory and clinical experience, our premier team of life science experts have the specialized skills to assist clients across therapeutic areas, modalities and markets.

Market Solutions

Pathway Solutions

As former regulators and industry leaders, our understanding of the product lifecycle is unrivaled. Clients turn to our team for strategic direction and hands-on execution services that support the earliest phases of development to post-approval and beyond.

Pathway Solutions

Global Solutions

ELIQUENT’S established and growing global presence spans the regulatory process and major markets. Our premier team of global regulatory experts support markets across the U.S., Europe, and Asia.

Global Solutions

ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly to provide a full-service engagement that delivers end-to-end support. No matter your pathway position, regulatory requirements, global market or therapeutic area – ELIQUENT’s integrated solutions align with your regulatory goals to unlock regulatory success.

Regulatory Affairs Solutions

PV+ Postmarket Surveillance

Quality & Compliance

Remediation Solutions

Talent Solutions

From the earliest phases of innovation through regulatory submissions, to post- approval support, our robust blend of technical skill and clinical expertise guide companies to approval and beyond.

With an approach that includes both strategic direction and hands-on global support, ELIQUENT’s customized pharmacovigilance solutions empower companies to operate with confidence.

Our team of highly specialized quality & compliance experts build customized solutions that equip companies with best-in-class strategic support, technical expertise, and project-based solutions.

ELIQUENT’s Remediation Solutions address challenges head-on, providing the expert guidance life science innovators need to bring your operations back into compliance and securing your path forward.

Whether you need a team of one or 100+, ELIQUENT’s talent solutions gives you the ability to rapidly scale your team to the right size, with the right level of expertise, in the right locations.

Your resource for regulatory clarity.

IQ Central is your resource for industry insights, expert perspectives, and valuable tools. Here, you’ll find a comprehensive collection of collateral, expert resources, and thought leadership designed to support your goals and keep you informed on the latest trends and help you navigate today’s regulatory landscape.

RESOURCES

Information Sheet

ELIQUENT’s Industry Due Diligence Solutions

Download Info Sheet

Information Sheet

ELIQUENT’s Integrated Solutions for Full-Service Support

Download Info Sheet

THOUGHT LEADERSHIP

Impact of R&D Quality Systems & Data Integrity in Drug Development

Read Steven Bowen, Ph.D.’s article in the Journal of Pharmaceutical Sciences.

Read more

Case Study: Global Regulatory Solutions

Learn how ELIQUENT Japan guided a global immunology company to regulatory success.

Read more

SOLUTIONS

Regulatory Writing

Explore ELIQUENT’s Regulatory & Medical Writing Solutions.

Regulatory Writing Solutions

QMSR

Explore ELIQUENT’s Quality Management System Regulation (QMSR) Solutions.

QMSR Solutions

Ready for regulatory clarity? Contact us.